Mechanical Thrombectomy for Stroke
(EVEREST Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effectiveness and safety of using a stent (a small tube to keep blood vessels open) along with mechanical thrombectomy (a procedure to remove clots) for treating strokes. It targets individuals with a major artery blockage in the brain who still have a narrowed artery after an initial clot removal attempt. Those who have experienced a stroke and have severe symptoms, such as difficulty speaking or moving, may be suitable candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking advancements in stroke treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that adding stenting to a procedure called mechanical thrombectomy for stroke patients can be safe. One study found that patients who received stenting after thrombectomy were more likely to regain independence within 90 days. This study also demonstrated that stenting restored blood flow in more patients compared to thrombectomy alone.
The safety information is generally positive, with no significant increase in serious side effects like bleeding in the brain. However, real-world safety data remains limited. So far, evidence suggests that stenting is well-tolerated and can be a safe option when used with thrombectomy.12345Why do researchers think this study treatment might be promising for stroke?
Researchers are excited about mechanical thrombectomy combined with adjunct stenting for stroke because it has the potential to enhance blood flow restoration more effectively than thrombectomy alone. Unlike standard treatments that typically involve just removing the clot, this approach includes placing a stent to keep the artery open, which might reduce the risk of re-occlusion and improve patient outcomes. This combined method could lead to better recovery rates and faster improvement in neurological function, offering a promising advancement over current standard care.
What evidence suggests that mechanical thrombectomy plus adjunct stenting could be effective for stroke?
Research has shown that using stents with a procedure called mechanical thrombectomy (MT) can effectively treat strokes. In this trial, participants will be randomized to receive either MT plus adjunct stenting or MT alone. Studies have indicated that patients receiving both stents and MT experienced better recovery rates. Specifically, 42.2% of these patients lived independently without assistance after 90 days, compared to 28.4% who only underwent MT. Additionally, blood flow was successfully restored in about 89.7% of cases. This approach appears to help more people regain independence after a stroke.14678
Who Is on the Research Team?
Tanya Siddiqui
Principal Investigator
ProMedica Health System
Sami Al Kasab, MD
Principal Investigator
Medical University of South Carolina
Mouhammad Jumaa, MD
Principal Investigator
ProMedica Toledo Hospital
Are You a Good Fit for This Trial?
This trial is for adults aged 18-80 who have had a recent stroke caused by a blocked large brain artery, and after initial clot removal still have severe narrowing (70-99%) in that artery. Participants must be able to start treatment within 24 hours of stroke onset and meet certain health criteria.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo mechanical thrombectomy (MT) with or without adjunct stenting
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Mechanical Thrombectomy plus adjunct stenting
Trial Overview
The study compares two treatments for severe strokes: one group receives standard mechanical thrombectomy (clot removal), while the other gets thrombectomy plus an additional procedure called stenting if there’s significant remaining narrowing in the artery.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Patients will have mechanical thrombectomy (MT) and stenting
Patients will only have mechanical thrombectomy (MT) done
Find a Clinic Near You
Who Is Running the Clinical Trial?
ProMedica Health System
Lead Sponsor
Citations
The RESCUE-ICAS Registry | Stroke
Functional independence at 90 days was significantly higher in the stenting group (42.2% versus 28.4%, adjusted odds ratio, 2.67 [95% CI, 1.66– ...
Outcomes of Adjunct Emergent Stenting Versus ...
Functional independence at 90 days was significantly higher in the stenting group (42.2% versus 28.4%, adjusted odds ratio, 2.67 [95% CI, 1.66- ...
3.
researchgate.net
researchgate.net/publication/386052447_Outcomes_of_Adjunct_Emergent_Stenting_Versus_Mechanical_Thrombectomy_Alone_The_RESCUE-ICAS_Registry(PDF) Outcomes of Adjunct Emergent Stenting Versus ...
Objectives To report efficacy and outcome of mechanical thrombectomy for treatment of pediatric acute ischemic stroke with large vessel ...
Safety and Efficacy of Mechanical Thrombectomy with ...
The success of recanalization was achieved in 89.7% and the recanalization rate varied from 66.7% to 100% in all 13 studies. The overall rates ...
Cost-Utility Analysis of Mechanical Thrombectomy Using Stent ...
The probabilistic sensitivity analysis demonstrated that thrombectomy had a 100% probability of being cost-effective at the minimum willingness to pay for a ...
Outcomes of Adjunct Emergent Stenting Versus ...
There was a higher rate of successful reperfusion (modified Treatment In Cerebral Infarction score ≥ 2B) in the stenting versus mechanical ...
Functional and Safety Outcomes of Carotid Artery Stenting ...
Mechanical thrombectomy (MT) was recently found to be beneficial in patients with LVO acute ischemic stroke with TLs. However, there is ...
a systematic review and meta-analysis of observational data
We conducted a systematic review and meta-analysis to report on observational data comparing safety and efficacy outcomes in patients with MT.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.